Health TrialsbyHealthPanel

SRS Compared With FSRS for Treatment of Intact Metastatic Brain Disease, FRACTIONATE Trial

ConditionsMetastatic Malignant Neoplasm in the BrainMetastatic Malignant Solid Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

This phase II trial compares the effect of single fraction stereotactic radiosurgery to fractionated stereotactic radiosurgery for the treatment of patients with cancer that has spread to the brain (metastatic brain disease). Stereotactic radiosurgery (SRS) is a form of radiation therapy that focuses high-power energy on a small area of the body. This trial is being done to determine if single (one) fraction stereotactic radiosurgery is better than fractionated stereotactic radiosurgery or vice versa in controlling tumor and side effects in patients with tumors that have spread to the brain.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years old

Presence of presumed brain metastases from an extra-cerebral tumor site (e.g. lung, breast, prostate, etc.)

Note: Dural based metastases (e.g. commonly seen in breast cancer) are eligible

Size of brain metastases

Disqualifiers

Any patient who has received previous whole brain radiation

Any brain metastasis that is located in the brainstem measuring >= 2.0 cm in maximal extent

Any patient with definitive evidence of leptomeningeal metastasis (LMD)

NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or unequivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Stereotactic Radiosurgery

    Radiation

    Undergo single fraction SRS

  • Stereotactic Radiosurgery

    Radiation

    Undergo fractionated SRS

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Arm A (single fraction SRS)Other 3 interventions
Group B: Arm B (fractionated SRS)Other 3 interventions

Trial outcomes

Primary outcomes

1

Time to local failure or symptomatic radiation brain necrosis of large brain metastasis

Will determine if the composite endpoint of time to local failure or symptomatic radiation brain necrosis of a large brain metastasis \[cumulative treatment failure (CTF)\] is increased with fractionated stereotactic radiosurgery (FSRS) compared to single fraction stereotactic radiosurgery (SSRS).

Time frame
Up to 5 years

Secondary outcomes

1

Overall survival (OS)

OS will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms. Medians and 95% confidence intervals will be reported.

Time frame
From study entry to death from any cause, assessed up to 5 years
2

Incidence of adverse events

The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.

Time frame
Up to 2 years post radiation therapy
3

Rates of radiation necrosis

Will compare rates of radiation necrosis in patients who receive FSRS to patients who receive SSRS. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.

Time frame
Up to 5 years
4

Central nervous system (CNS) failure patterns (Fractionation)

Will evaluate if there is any difference in CNS failure patterns (e.g. local, distant brain failure) in patients who receive FSRS compared to patients who receive SSRS. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now